Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003777
Recruitment Status : Unknown
Verified November 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : December 10, 2003
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: amifostine trihydrate Drug: cisplatin Drug: fluorouracil Procedure: surgical procedure Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine the effectiveness and toxic effects of intensive salvage therapy and radiotherapy in previously irradiated patients with recurrent head and neck cancer.
  • Determine the feasibility and effectiveness of amifostine at limiting or minimizing side effects of repeat irradiation in these patients.

OUTLINE: Patients undergo surgical resection of gross disease (if not already done) followed by 4-6 weeks of rest. Patients receive radiotherapy over 5 consecutive days on weeks 1, 2, 4, and 5. Intravenous cisplatin is administered on days 1-3 and 29-31. Intravenous amifostine is administered 15-30 minutes prior to radiotherapy and cisplatin therapy. Patients receive fluorouracil IV continuously on days 1-4 and 29-32.

Patients are followed every month for 1 year, every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Primary Purpose: Treatment
Official Title: A Pilot Study of Combined Modality Therapy for Recurrent Head and Neck Carcinoma
Study Start Date : December 1998

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed recurrent or new primary squamous cell carcinoma of the head and neck occurring in a previously irradiated field
  • Pathologic stage of recurrence must be rT3-4 and/or rN2-3
  • The following sites are eligible:

    • Oral cavity, oropharynx, or hypopharynx: Any rT2-4 and/or clinical rN+
    • Larynx: Any rT4, rT3 with perineural invasion, or any rT with clinical rN+
    • Any site: Positive margin(s), at least 2 nodes or ECS
  • No primary tumor of the nasopharynx
  • Must be eligible for or have undergone complete resection which leaves behind no gross residual disease
  • Must have prior head and neck irradiation of 45-75 Gy
  • Lifetime spinal cord radiotherapy dose no greater than 50 Gy
  • No ongoing RTOG late morbidity of grade 3 or greater (unless correctable by surgery)
  • No active acute radiation mucositis from previous radiotherapy



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified


  • WBC at least 4,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)
  • Platelet count at least 100,000/mm^3


  • SGOT or SGPT no greater than 3 times upper limit of normal
  • Bilirubin no greater than 2 mg/dL


  • Creatinine no greater than 1.5 mg/dL


  • No myocardial infarction, unstable angina, coronary heart failure, or uncontrolled arrhythmias within past 6 months
  • No severe cerebrovascular disease or hypotension not caused by antihypertensive medication


  • Not pregnant
  • Fertile patients must use effective contraception
  • No allergy to cisplatin, fluorouracil, or amifostine
  • No uncontrolled insulin-dependent diabetes mellitus or other medical condition interfering with wound healing


Biologic therapy:

  • Not specified


  • No prior chemotherapy for tumor recurrence (except adjuvant chemotherapy)

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • At least 6 months since prior radiotherapy
  • Prior radiotherapy treatment records must be available


  • No prior salvage surgery consisting of partial laryngectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003777

United States, Pennsylvania
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
University of Pennsylvania
Study Chair: Mitchell Machtay, MD Abramson Cancer Center of the University of Pennsylvania Identifier: NCT00003777     History of Changes
Other Study ID Numbers: CDR0000066906
First Posted: December 10, 2003    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: November 2002

Keywords provided by National Cancer Institute (NCI):
stage III lip and oral cavity cancer
stage IV lip and oral cavity cancer
recurrent lip and oral cavity cancer
stage III hypopharyngeal cancer
stage IV hypopharyngeal cancer
recurrent hypopharyngeal cancer
stage III laryngeal cancer
stage IV laryngeal cancer
recurrent laryngeal cancer
stage III paranasal sinus and nasal cavity cancer
stage IV paranasal sinus and nasal cavity cancer
recurrent paranasal sinus and nasal cavity cancer
stage III oropharyngeal cancer
stage IV oropharyngeal cancer
recurrent oropharyngeal cancer

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents